Aplicare, Inc.
FDA inspection history in Meriden, Connecticut, 2016 to 2021
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter, at Meriden, Connecticut.
- 2021One Form 483, at Meriden, Connecticut.
Cited most
Across all Aplicare observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
- 21 CFR 211.46(b)Ventilation, air filtration, air heating and cooling1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Aplicare file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Meriden, Connecticut
One Form 483 and one warning letter · 2016 to 2021 · 4 observations
Latest: Form 483, Aug 3, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-03 | 483 Form 483 | Meriden, Connecticut | 4 | $99 |
| 2016-12-15 | Warning letter Warning letter | Meriden, Connecticut | — | $99 |
Investigators on these documents
FEI number 1220701 · most recent document Aug 3, 2021
About Aplicare, Inc.
How many FDA Form 483s has Aplicare, Inc. received?
FDA Intel has 1 Form 483 on file for Aplicare, Inc.; the most recent is dated Aug 3, 2021.
When was Aplicare, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Aplicare, Inc. is a Form 483 dated Aug 3, 2021, for the site in Meriden, Connecticut.
What did FDA cite at Aplicare, Inc.?
The regulations cited most in the observations on file for Aplicare, Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 1 time; 21 CFR 211.46(b) (Ventilation, air filtration, air heating and cooling), 1 time.
Has Aplicare, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aplicare, Inc.; the most recent is dated Dec 15, 2016.